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Continuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine

NCT01089569 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-05-23

Study results available
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Summary

The primary purpose of this study is to compare the effect on 24-hour blood glucose patterns, HbA1c, and weight management when adding insulin glargine, or exenatide, or a combination of insulin glargine and exenatide to metformin.

Conditions

Interventions

DRUG

Exenatide

5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study

DRUG

Insulin Glargine

.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results

Sponsors & Collaborators

  • International Diabetes Center at Park Nicollet

    collaborator OTHER

  • Sanofi

    collaborator INDUSTRY

  • HealthPartners Institute

    lead OTHER

Principal Investigators

  • Richard M Bergenstal, MD · International Diabetes Center at Park Nicollet

  • Roger S Mazze, PhD · International Diabetes Center at Park Nicollet

  • Elinor S Strock, APRN · International Diabetes Center at Park Nicollet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01089569 on ClinicalTrials.gov